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TerminatedPhase 1NCT00268151
Official study title

Oxaliplatin in Combination With Capecitabine and Concurrent Radiation Therapy in Non-Small Cell Lung Cancer

Study summary

The purpose of this study is to determine the most suitable dose of Oxaliplatin that can be safely given in combination with a low fixed dose of Capecitabine and a limited volume of radiation in patients with non-small cell lung cancer.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedOxaliplatin and Capecitabine

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 5, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?University of Louisville

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
University of Louisville
Interventions being studied
Drug: Oxaliplatin; Drug: Capecitabine
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Treatment approach
Radiation therapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • histologically proven non-small cell lung cancer
  • inoperable Stage III A or B NSCLC
  • must have measurable disease by RECIST criteria
  • no more than one prior chemotherapy for advanced disease
  • ECOG Performance Status of 0, 1, or 2
  • must be able to swallow pills or have a working gastric feeding tube and no evidence of malabsorption
  • negative serum beta-HCG test and under active contraception (for females of childbearing potential)
  • no known allergies to any of the study drugs
  • willingness to sign an informed consent
Reasons someone may not be able to joinExclusion criteria
  • women who are pregnant or breastfeeding
  • ANC of less than 1500/mm3
  • platelet count of less than 100,000/mm3
  • estimated creatinine clearance of less than 50 cc/min (as measured by the Cockcroft-Gault equation)
  • bilirubin of less than 2mg/dl
  • SGPT of greater than 2x nl
  • peripheral neuropathy of Grade 2 or higher
  • more than one previous chemotherapy and previous radiation therapy to the chest
  • a history of CHF/MI or other significant cardiac history within the last six months

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • James Graham Brown Cancer CenterLouisville, Kentucky

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 5, 2018. Always confirm current availability with the study team.

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